- Parexel (Boston, MA)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios - Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness - Participate in monthly CMC Global Regulatory Team meetings… more
- Parexel (Boston, MA)
- …Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and ... Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role,...role, you will be responsible for developing and executing global regulatory strategies for our clients' marketed… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** The Global Regulatory Affairs , Chemistry, Manufacturing, and Controls (GRA CMC ) team resides within Takeda's ... complex regulatory environment, we partner to develop and execute innovative CMC regulatory strategies to provide high-quality medicines and technologies to… more
- Takeda Pharmaceuticals (Boston, MA)
- …Production, Quality Assurance can be considered. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development ... as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned… more
- Parexel (Boston, MA)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement CMC strategies to enable data driven ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
- Takeda Pharmaceuticals (Boston, MA)
- …with functional areas from quality, process experts, product experts, device experts, and regulatory affairs . + Works with supervisor for alignment on project ... risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product /… more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Sumitomo Pharma (Boston, MA)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... of the product + Supports the global regulatory lead (GRL) and the CMC ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Sumitomo Pharma (Boston, MA)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Bausch + Lomb (Boston, MA)
- …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA,...of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work… more
- Parexel (Boston, MA)
- …Are you a strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and ... Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role,...role, you will be responsible for developing and executing global regulatory strategies for our clients' marketed… more
- Bristol Myers Squibb (Cambridge, MA)
- …preferred. + 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs . Global experience strongly preferred with command ... work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director, Global Regulatory Strategy, Neuroscience** + Will be a key member… more
- Sanofi Group (Cambridge, MA)
- …with all key stakeholder in GPT and Global Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the ... R&D components of the brand optimization strategy in close collaboration with Market Access, Global Commercial and Medical Affairs , as Active member of GPT. +… more
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global ), in early ... teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner...and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated… more
- Bristol Myers Squibb (Cambridge, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Global Program Leads within the ICV Global Program Leadership ... late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing ... best of my knowledge. **Job Description** **Title: Process Scientist - Global Manufacturing Science GMSci DP/PKG** **Location: Cambridge, MA** **About the role:**… more
- Sanofi Group (Framingham, MA)
- …needed, and consults with functional leadership, influences other organizations (Operations, Quality, Regulatory Affairs , CMC Dev/R&D and internal and/or ... new product industrialization, validation, Pre-Approval Inspections, and address technical regulatory matters in partnership with CMC -Development teams while… more
